Technical Articles
11 Apr 2025
Crystal’s Perspective: Polymorph Patent Landscape of 28 FDA-Approved Small Molecule Drugs in 2024
11 Apr 2025
Biologics also referred to as Biopharmaceuticals, and are regulated in USA by the Center for Biologics Evaluation and Research (CBER) division of FDA. These biologics need to go through different clinical phases (I, II, and III) of drug development followed by the Biologics Licensing Application (BLA) process for approval by FDA prior to commercialization and marketing.